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Not yet recruiting NCT05339256

Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

Phase II Interventional Opioid Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Buprenorphine SL, Telehealth, In-person treatment as usual.
Who it may be relevant to
Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Controlled Trial of Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder

Overview

This study will compare in-person induction and maintenance dosing of sublingual buprenorphine to induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions and telehealth medication for opioid use disorder (MOUD).

Detailed description

The study is a 12-week, randomized, active-control, open-label, early phase II effectiveness trial of telemedicine treatment using sublingual buprenorphine as compared to in person clinic treatment with sublingual buprenorphine for outpatients seeking treatment for opioid use disorder (OUD). This telehealth protocol serves as a model of the integration of evidence-based practices in medication for opioid use disorder (MOUD) and could be used by non addiction specialists at scale. The primary outcome will be time to dropout. Participants will have daily study visits (either in person or remote) during the initial buprenorphine induction week and then twice per week during the maintenance phase (either in person or remote) over the 12-week trial. Remote visits will be conducted using the HIPAA-compliant technology, FaceTime and/or Webex.

Interventions

  • Drug Buprenorphine SL
    Up to 24 mg per day
  • Other Telehealth
    Telehealth MOUD, utilizing a standardized protocol for each healthcare provider session
  • Other In-person treatment as usual
    in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.

Primary outcome measures

  • Time to drop out [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • meet DSM-5 criteria for OUD
  • Voluntarily seeking buprenorphine treatment for OUD
  • Able to provide informed consent and comply with study procedures

Exclusion criteria

  • Meeting DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis that would compromise safety of participation in the trial as determined by the study physician, such as an alcohol or sedative hypnotic use disorder that requires detoxification
  • Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as a psychotic disorder including schizophrenia or schizoaffective disorder
  • Concurrent methadone, buprenorphine, or vivitrol maintenance treatment
  • Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
  • Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients
  • Unstable medical conditions, such as severe hepatic, renal, or cardiovascular disease, which might make participation
  • Current or recent history history of significant violent or suicidal behavior or risk for suicide or homicide
  • Legally mandated to substance use disorder treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05339256 · 8305 · R21DA055835

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗